{"id":1880,"date":"2023-05-05T17:47:00","date_gmt":"2023-05-05T15:47:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1880"},"modified":"2024-03-30T17:49:42","modified_gmt":"2024-03-30T16:49:42","slug":"34-liecivo-pembrolizumab-keytruda-v-monoterapii-na-adjuvantnu-liecbu-maligneho-melanomu","status":"publish","type":"post","link":"https:\/\/www.niho.sk\/en\/34-liecivo-pembrolizumab-keytruda-v-monoterapii-na-adjuvantnu-liecbu-maligneho-melanomu\/","title":{"rendered":"34: Lie\u010divo pembrolizumab (Keytruda) v monoterapii na adjuvantn\u00fa lie\u010dbu mal\u00edgneho melan\u00f3mu"},"content":{"rendered":"
    \n
  1. Ak\u00e1 je z\u00e1\u0165a\u017e ochorenia pre pacienta? Ako z\u00e1sadn\u00e9 je ochorenie?<\/strong><\/li>\n<\/ol>\n\n\n\n

    Mal\u00edgny melan\u00f3m patr\u00ed medzi najagres\u00edvnej\u0161ie n\u00e1dorov\u00e9 ochorenia s relat\u00edvne r\u00fdchlym \u0161\u00edren\u00edm lymfatickou a krvnou cestou do vzdialen\u00fdch org\u00e1nov. Aj ke\u010f nepatr\u00ed na Slovensku medzi zhubn\u00e9 n\u00e1dory s najvy\u0161\u0161ou incidenciou, pozorujeme strojn\u00e1sobenie jeho v\u00fdskytu za posledn\u00fdch 30 rokov. Z\u00e1va\u017enos\u0165 ochorenia spo\u010d\u00edva aj v relat\u00edvne vysokej \u00famrtnosti, najm\u00e4 v pr\u00edpade, ak je zachyten\u00fd v neskor\u0161\u00edch \u0161t\u00e1di\u00e1ch ochorenia.<\/p>\n\n\n\n

      \n
    1. O ak\u00fd liek ide?<\/strong><\/li>\n<\/ol>\n\n\n\n

      KEYTRUDA obsahuje lie\u010divo pembrolizumab, ktor\u00fd je monoklon\u00e1lna protil\u00e1tka. KEYTRUDA \u00fa\u010dinkuje tak, \u017ee pom\u00e1ha v\u00e1\u0161mu imunitn\u00e9mu syst\u00e9mu bojova\u0165 proti rakovine.<\/p>\n\n\n\n

      Predmetom tohto hodnotenia je pou\u017eitie lieku Keytruda v indik\u00e1cii melan\u00f3mu u dospel\u00fdch v \u0161t\u00e1di\u00e1ch IIB, IIC a III v adjuvantnej lie\u010dbe, ktor\u00e9 bolo v EMA (Eur\u00f3pskej liekovej agent\u00fare) schv\u00e1len\u00e9 vo febru\u00e1ri 2019 pre \u0161t\u00e1dium III a j\u00fani 2022 pre \u0161t\u00e1di\u00e1 IIB a IIC.<\/p>\n\n\n\n

        \n
      1. Ako sa na hodnoten\u00e9 lie\u010divo pozeraj\u00fa odborn\u00edci? <\/strong><\/li>\n<\/ol>\n\n\n\n

        Klinick\u00fd odborn\u00edk a Slovensk\u00e1 onkologick\u00e1 spolo\u010dnos\u0165 by priv\u00edtali kategoriz\u00e1ciu pembrolizumabu v indik\u00e1cii adjuvantnej lie\u010dby mal\u00edgneho melan\u00f3mu. Poukazuj\u00fa na nenaplnen\u00fa medic\u00ednsku potrebu na Slovensku, nako\u013eko v tejto indik\u00e1cii zatia\u013e nie je hraden\u00e9 alternat\u00edvne lie\u010divo a pacienti s\u00fa len na pozorovan\u00ed bez akt\u00edvnej lie\u010dby. V \u010dase zverejnenia hodnotenia prebieha kategoriza\u010dn\u00fd proces kombin\u00e1cie lie\u010div dabrafenib a trametinib. V pr\u00edpade ich zaradenia do zoznamu kategorizovan\u00fdch liekov bude pre \u010das\u0165 pacientov (pozit\u00edvnych na BRAF mut\u00e1ciu v III. \u0161t\u00e1diu ochorenia) pr\u00edstupn\u00fd alternat\u00edvny liek.<\/p>\n\n\n\n

          \n
        1. \u010co hodnotilo NIHO a ak\u00fd je v\u00fdsledok?<\/strong><\/li>\n<\/ol>\n\n\n\n

          Dr\u017eite\u013e registr\u00e1cie (Merck Sharp & Dohme B.V. (NLD)) podal \u017eiados\u0165 o zaradenie lie\u010diva pembrolizumab (Keytruda) v monoterapii na adjuvantn\u00fa lie\u010dbu mal\u00edgneho melan\u00f3mu.<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Keytruda v predmetnej indik\u00e1ci\u00ed, nako\u013eko v\u00fd\u0161ka \u00fahrady sp\u013a\u0148a z\u00e1konn\u00e9 krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti.<\/p>\n\n\n\n

          V\u00fdsledok hodnotenia n\u00e1kladovej efekt\u00edvnosti je aj pri danej \u00fahrade spojen\u00fd s vysokou mierou neistoty, \u017ee v klinickej praxi nebud\u00fa splnen\u00e9 krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti. Preto NIHO odpor\u00fa\u010da po\u017eadova\u0165 od dr\u017eite\u013ea registr\u00e1cie adekv\u00e1tnu dodato\u010dn\u00fa z\u013eavu, ktorou by sa t\u00e1to neistota kompenzovala.<\/p>\n\n\n\n

          Z\u00e1rove\u0148 NIHO odpor\u00fa\u010da zv\u00e1\u017ei\u0165 doplnenie indika\u010dn\u00e9ho obmedzenia o dobr\u00fd v\u00fdkonnostn\u00fd stav pacienta.<\/p>","protected":false},"excerpt":{"rendered":"

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Keytruda v predmetnej indik\u00e1ci\u00ed, nako\u013eko v\u00fd\u0161ka \u00fahrady sp\u013a\u0148a z\u00e1konn\u00e9 krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti…<\/p>","protected":false},"author":3,"featured_media":1857,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[92,93],"class_list":["post-1880","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-keytruda","tag-pembrolizumab"],"_links":{"self":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1880","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/comments?post=1880"}],"version-history":[{"count":0,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1880\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media\/1857"}],"wp:attachment":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1880"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1880"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1880"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}